MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-10-24 for THINPREP * 70097-001 manufactured by Hologic, Inc..
[18926160]
Patient had a routine pap smear then complained for 8 days of abdominal pain and vaginal bleeding (on and off, 1 pad/day), with associated chills. She also reported feeling something "hard" in her vagina. Later, it was determined that a piece of the security seal that prevents tampering with the specimen jar cover became separated from the rest of the seal and ended up in the patient's vagina.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4234216 |
| MDR Report Key | 4234216 |
| Date Received | 2014-10-24 |
| Date of Report | 2014-10-24 |
| Date of Event | 2014-07-10 |
| Report Date | 2014-10-24 |
| Date Reported to FDA | 2014-10-24 |
| Date Reported to Mfgr | 2014-11-07 |
| Date Added to Maude | 2014-11-07 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THINPREP |
| Generic Name | PROCESSOR, CERVICAL CYTOLOGY |
| Product Code | MNM |
| Date Received | 2014-10-24 |
| Model Number | * |
| Catalog Number | 70097-001 |
| Lot Number | 4127BA |
| ID Number | * |
| Operator | NURSE |
| Device Availability | N |
| Device Age | 3 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC. |
| Manufacturer Address | 35 CROSBY DRIVE BEDFORD MA 01730 US 01730 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-24 |